Attachment 1- Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENTS

Acquisition of a Mass Spectrometer with UHPLC Systems

I. BACKGROUND INFORMATION

The Biomolecular Measurement Division of the Materials Measurement Laboratory at the

National Institute of Standards and Technology (NIST) (1) advances novel measurement methods and models for the determination and analysis of the structure and function of biological macromolecules and their complexes; (2) advances methods to determine the physical and chemical factors which determine the specific interactions of macromolecules with cofactors and ligands; (3) studies the relationships between biomolecule structure, dynamics, function, and energetics using computational, biophysical and biochemical techniques; (4) develops reference databases for these properties; and (5) advances measurement methods for engineering complex biological systems. In addition to meeting the needs for these programmatic activities, the desired liquid chromatography mass spectrometry (LC-MS) instrumentation is required for determining identity, purity, stability, and higher order structure of protein therapeutics, vaccines, and their process and product related impurities. The LC-MS instrumentation is especially needed for (re)certification and stability assessment of current and planned NIST

RMs. NIST is seeking a brand name only for an Orbitrap Ascend tribrid mass spectrometer with

Vanquish LC systems manufactured by Thermo Electron North America, which is required in the instrument sought to match previous NIST RM technologies and data.

II. GENERAL REQUIREMENTS

The Contractor shall deliver an analytical instrument inclusive of one (1) Orbitrap Ascend tribrid mass spectrometer and two (2) Vanquish ultra high performance liquid chromatography

(UHPLC) systems, inclusive of FOB destination delivery, installation, warranty, training, and option line items. Mass spectrometer must be a hybrid mass spectrometer that combines quadrupole, linear ion trap, and Orbitrap mass analyzers and features collision induced dissociation (CID), higher-energy C-trap dissociation (HCD), electron transfer dissociation

(ETD), and ultraviolet photodissociation (UVPD) fragmentation techniques. UHPLC systems must be compatible with mass spectrometer and must meet needs for certification of NIST RMs, hydrogen-deuterium exchange mass spectrometry (HDX-MS), and oligonucleotide analysis activities.

III. SPECIFICATIONS

The Contractor shall provide a system that meets all technical specifications identified below. All items must be new. Used or remanufactured equipment will not be considered for award.

Experimental, prototype, or custom items will not be considered. The use of “gray market” components are not authorized for sale in the U.S. by the Contractor is not acceptable. All line items shall be shipped in the original manufacturer’s packaging and include all original documentation and software, when applicable. Additionally, the system must be directly compatible with current NIST-IBBR technologies (orbitrap mass analyzers, CID, HCD, ETD, UHPLC) developed for the NISTmAb RM 8671 and HDX-MS. Operations and maintenance manual in electronic format for the analytical instrument must be included. Specific instrument components and specifications that will provide this functionality are described in more detail below:

CLIN 0001:

Description- Hybrid mass spectrometer that combines quadrupole, linear ion trap, and

Orbitrap mass analyzers

Quantity: 1

A. Technical Specifications- Shall include all of the following:

a. Hybrid mass spectrometer that combines quadrupole, linear ion trap, and Orbitrap mass analyzers and features CID and HCD fragmentation techniques, available at any stage of MSn analysis, with subsequent mass analysis in either ion trap or

Orbitrap mass analyzer. Each mass analyzer must be able to work sequentially or in parallel with the others. The operation of the three mass analyzers must be under Dynamic Scan Management for operational efficiency.

b. Must include Ultraviolet Photodissociation (UVPD) that allows for photodissociation of the ions of interest using a Class 1 UV laser with 213 nm wavelength, repetition rate of 2.5 kHz and pulse energy exceeding 1.2 micro J.

c. Must include easy Electron Transfer Dissociation (ETD).

d. Must be upgradeable to perform proton transfer charge reduction.

e. Two ion sources, which feature the ability to adjust the sprayer vertically to achieve optimum spray conditions. Gas and voltage connections are established automatically. Ion source includes one HESI sprayer.

f. Ion Source generating internal calibrant ions for real-time mass calibration of any

Orbitrap spectrum.

g. A vacuum system containing a split-flow turbomolecular pump, which controls the vacuum in multiple regions. Enhanced Vacuum Technology for improved vacuum in the C-trap and Orbitrap analyzer regions resulting in improved ion transfer to the Orbitrap mass analyzer.

h. High-Capacity Transfer Tube and an Electrodynamic Ion Funnel to capture and efficiently focus ions in a tight beam.

i. Advanced Active Beam Guide to reduce noise by preventing neutrals and high velocity clusters from entering the quadrupole mass filter.

j. QR5 Segmented Quadrupole Mass Filter consisting of segmented 5.25 mm field radius quadrupole mass analyzer with hyperbolic surfaces, providing excellent peak shape and high transmission with a minimum resolution of 0.4 FWHM.

k. An Orbitrap Mass Analyzer with an m/z range of 50-6000, resolving power of up to 480,000 FWHM and isotopic fidelity of up to 240,000 FWHM at m/z 200.

l. A Dual-Pressure Linear Ion Trap used for MSn precursor ion isolation and collision induced dissociation (CID). The ions are detected at a maximum scan rate of 45 Hz using a dual-dynode detector with high linear dynamic range for improved quantitation and a large surface area for increased lifespan and robustness.

m. Independent dual barrel syringe pump and injector/divert valve with mounting bracket, which are both controlled via the data station for maximum flexibility.

n. High performance PC with Microsoft Windows 10 Enterprise or newer (Long

Term Service version) operating system

o. License for Xcalibur software

p. 27 inch or larger monitor

q. Oil-free/dry fore-line pump

r. Include UPS and necessary power connections compatible with the instrument.

s. The mass spectrometer must have dimensions of no more than 1270 x 805 x 703 mm (w, d, h).

t. Ability to send and/or receive a Start In/Out contact closure signal and a programmable Start Out contact closure.

Description- Complete UHPLC system with binary pump

Quantity: 1

A. General Technical Specifications- Shall include all of the following:

a. The UHPLC shall consist of a multisampler, UHPLC pump with degassing capabilities, column oven, variable wavelength UV detector, and fraction collector.

b. Must include a stackable, self-contained modular UHPLC with solvent resistant material used in all areas which may have contact with the mobile phase.

c. UHPLC system must have a pH range 2 to 12.

d. UHPLC system must have operating pressure range up to 103 MPa (1034 bar) up to 5 ml/min, 80 MPa (800 bar) at 5 ml/min to ensure capability with HPLC and

UHPLC methods and optimally support all column dimensions.

B. UHPLC Binary Pump

a. UHPLC binary pump must be able to deliver and have settable flow range capable of 0.001-5mL, in ≤1 μL/min increments.

b. UHPLC pump must have a flow accuracy ±0.1%.

c. UHPLC pump must have flow precision of ≤0.05% RSD or ≤0.01 min SD, whatever is greater, for the best retention time precision and identification confidence.

d. UHPLC pump must have gradient proportioning accuracy of ±0.2% of full scale.

e. UHPLC pump must have gradient proportioning precision <0.15% SD.

f. UHPLC pump must have integrated 2-channel degassing unit.

C. UHPLC multisampler

a. UHPLC multisampler must have cooling capabilities down to 4 oC.

b. UHPLC mulitsampler must come equipped with two or more injection plates each capable of holding 54 or more standard HPLC vials. The injector must also be scalable to include additional drawers and injection plates all within the LC-stack footprint.

c. UHPLC multisampler must have outer needle wash for carryover reduction.

d. UHPLC multisampler must have carryover specification of < 0.002%.

e. UHPLC multisampler must have injection volume range of 0.01 to 25µL in 0.1 µL increments.

f. UHPLC multisampler must have injection volume precision of ≤0.25% area RSD for 1 μL.

D. UHPLC column oven/compartment

a. UHPLC column compartment must support columns of up to 30 cm length.

b. UHPLC Column compartment must have temperature range from 18 °C below ambient to 120 °C in 0.1 °C increments.

c. UHPLC column compartment temperature accuracy must be ± 0.5 °C.

d. UHPLC column compartment temperature stability must be ± 0.05 °C.

e. UHPLC column compartment must have an integrated 2Pos/6Port valve with the same pressure range as of the pump. Valves must be near columns.

f. UHPLC pump flow will be firmware controlled and reduced before a valve is switched.

E. UHPLC Variable Wavelength UV Detector

a. UHPLC VWD detector must be capable of single and dual (or more) wavelength detection at acquisition rates of 250 Hz and 5 Hz, respectively.

b. UHPLC VWD detector must have a wavelength range of at least 190 to 600 nm.

c. UHPLC VWD detector must have linearity < 5% at 2.5 AU.

d. UHPLC VWD detector noise (ASTM) must be ≤± 2.5 μAU at 254nm.

e. UHPLC VWD detector must have sampling rate of up to 250Hz (single wavelength acquisition) and up to 5 Hz (multi-wavelength acquisition).

f. UHPLC VWD detector signal drift must be < 0.1 mAU/h at 254 nm.

g. UHPLC VWD detector must have wavelength accuracy of ± 1 nm, and wavelength precision of ≤ ± 0.1 nm.

Description- Complete UHPLC system with dual pump

Quantity: 1

A. General Technical Specifications- Shall include all of the following:

a. The UHPLC shall consist of a multisampler, UHPLC dual pump with degassing capabilities, column oven, fluorescence detector, variable wavelength UV detector, and fraction collector.

b. Must include a stackable, self-contained modular UHPLC with solvent resistant material used in all areas which may have contact with the mobile phase.

c. UHPLC system must have a pH range 2 to 12.

d. UHPLC system must have operating pressure range up to 103 MPa (1034 bar) up to 5 ml/min, 80 MPa (800 bar) at 5 ml/min to ensure capability with HPLC and

UHPLC methods and optimally support all column dimensions.

B. UHPLC Dual Pump

a. UHPLC pump must be able to deliver and have settable flow range capable of

0.001-5mL, in ≤1 μL/min increments.

b. UHPLC pump must have a flow accuracy of ±0.1%.

c. UHPLC pump must have flow precision of ≤0.05% RSD or ≤0.01 min SD, whatever is greater, for the best retention time precision and identification confidence.

d. UHPLC pump must have gradient proportioning accuracy of ±0.2% of full scale.

e. UHPLC pump must have gradient proportioning precision <0.15% SD.

f. UHPLC pump must have integrated degassing unit.

g. UHPLC pump must have 2x3 solvent channels.

C. UHPLC multisampler

a. UHPLC multisampler must have cooling capabilities down to 4 oC.

b. UHPLC mulitsampler must come equipped with two or more injection plates each capable of holding 54 or more standard HPLC vials. The injector must also be scalable to include additional drawers and injection plates all within the LC-stack footprint.

c. UHPLC multisampler must have outer needle wash for carryover reduction.

d. UHPLC multisampler must have carryover specification of < 0.002%.

e. UHPLC multisampler must have injection volume range of 0.01 to 25µL in 0.1 µL increments.

f. UHPLC multisampler must have injection volume precision of ≤0.25% area RSD for 1 μL.

D. UHPLC column oven/compartment

a. UHPLC column compartment must support columns of up to 30 cm length.

b. UHPLC Column compartment must have temperature range from 18 °C below ambient to 120 °C in 0.1 °C increments.

c. UHPLC column compartment temperature accuracy must be ± 0.5 °C.

d. UHPLC column compartment temperature stability must be ± 0.05 °C.

e. UHPLC column compartment must have an integrated 2Pos/6Port valve with the same pressure range as of the pump. Valves must be near columns.

f. UHPLC pump flow will be firmware controlled and reduced before a valve is switched.

E. UHPLC Variable Wavelength UV Detector

a. UHPLC VWD detector must be capable of single and dual (or more) wavelength detection at acquisition rates of 250 Hz and 5 Hz, respectively.

b. UHPLC VWD detector must have a wavelength range of at least 190 to 600 nm.

c. UHPLC VWD detector must have linearity < 5% at 2.5 AU.

d. UHPLC VWD detector noise (ASTM) must be ≤± 2.5 μAU at 254nm.

e. UHPLC VWD detector must have sampling rate of up to 250Hz (single wavelength acquisition) and up to 5 Hz (multi-wavelength acquisition).

f. UHPLC VWD detector signal drift must be < 0.1 mAU/h at 254 nm.

g. UHPLC VWD detector must have wavelength accuracy of ± 1 nm, and wavelength precision of ≤ ± 0.1 nm.

F. UHPLC Fluorescence Detector

a. UHPLC fluorescence detector must be able to acquire spectra (excitation or emission) during the analysis (no stop flow needed).

b. UHPLC fluorescence detector must have a Raman signal-to-noise of ≥2100 when using dark signal as noise reference

c. UHPLC fluorescence detector must have Excitation wavelength range must be at least 200-630 nm, Emission wavelength range must be at least 220-650 nm.

d. UHPLC fluorescence detector must be Xenon flash lamp

e. UHPLC fluorescence detector must have flash lamp technology that can be switched on directly before the analysis and doesn’t require warm up time.

f. UHPLC detectors must have option for a bio-inert flow cell available.

g. UHPLC fluorescence detector must have wavelength accuracy of ± 2 nm and wavelength repeatability of ± 0.2 nm

h. UHPLC fluorescence detector must have wavelength switching time of <250ms

Description - Initial Warranty

Quantity: 1 Year

The Contractor shall provide, at a minimum, a one-year warranty for all equipment. The warranty shall cover all parts, labor and travel. The warranty shall provide unlimited onsite repair visits to repair instrumentation and onsite service shall be provided within 3 business days from the date the repair call is placed with the Contractor. The warranty shall commence upon acceptance by NIST after successful completion of delivery, installation, training and demonstration of all required specifications.

OPTION LINE ITEMS (CLIN 0002 – 0005):

Description: Extended Warranty and Preventative Maintenance Services

The following CLINS (0002 through 0005) are options for Extended Warranty and Preventative

Maintenance Services beyond the initial one-year warranty. The Contractor shall include options for four (4) years of extended warranty and preventative maintenance, in one (1) year increments, to cover all equipment. During the preventative maintenance service, the contractor shall inspect the instrument for necessary repairs, replace hardware parts as necessary, clean, tune and calibrate the instrument. Preventative Maintenance/Repair Services shall provide all labor, equipment, travel, and parts necessary for preventative maintenance/repairs for this equipment, shall provide unlimited on-site service for all required repairs not later than 3 business days from the date the repair call is placed with the Contractor, shall provide one preventative maintenance service visit per year.

CLIN 0002: Option Year 1, includes one (1) year of Extended Warranty and Preventative

Maintenance Services as outlined above.

CLIN 0003: Option Year 2, includes one (1) year of Extended Warranty and Preventative

Maintenance Services as outlined above.

CLIN 0004: Option Year 3, includes one (1) year of Extended Warranty and Preventative

Maintenance Services as outlined above.

CLIN 0005: Option Year 4, includes one (1) year of Extended Warranty and Preventative

Maintenance Services as outlined above.

IV. INSTALLATION

All installation work shall be accomplished at IBBR, 9600 Gudelsky Drive, Rockville, MD.

Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash.

Instrument shall operate to manufacturer’s specifications upon installation. Installation shall occur during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Contracting

Officer’s Representative (COR). Installation shall occur within 60 calendar days of delivery.

V. TRAINING

The Contractor shall provide in person training at NIST/IBBR for up to 4 NIST personnel covering normal operation, troubleshooting, and routine maintenance. Training will be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through

Friday, except Federal Holidays, and will be coordinated with the NIST COR to ensure maximum availability of NIST personnel. Training shall occur within 10 calendar days of installation. The training may be completed on-site at NIST immediately after successful completion of installation and demonstration of specifications.

VI. PERIOD OF PERFORMANCE

Delivery Date is 90 calendar days from award. Anticipated dates for base and option years for initial and extended warranty are as follows:

Base year: FY24 to FY25 – 12 months from the date of Government Acceptance.

Option year 1: FY25 to FY26 – 12 months from the expiration of the initial warranty.

Option year 2: FY26 to FY27 – 12 months from the expiration of the previous option year.

Option year 3: FY27 to FY28 - 12 months from the expiration of the previous option year.

Option year 4: FY28 to FY29 - 12 months from the expiration of the previous option year.

The period of performance for the option years in any resultant award will be estimated based on the date of award, required delivery, installation, and training. If/when Option Year 1- Extended

Warranty and Preventative Maintenance Services is exercised; the periods of performance for all future Options will be firmed via a bilateral modification.

VII. PLACE OF PERFORMANCE

Installation of the instrument, training, and extended warranty and PM services shall be accomplished at NIST/IBBR, Rockville, Maryland. Normal duty hours are Monday through

Friday, 8:30 a.m. to 5:00 p.m. except for Federal holidays.

VIII. DELIVERABLES

Description Quantity Due Date

Analytical instrument (CLIN 0001) One (1) each

90 calendar days after award of this requirement.

Operations and maintenance manual for the analytical instrument

One (1) 90 calendar days after award of this requirement

Installation Once 60 calendar days after delivery of this requirement.

Training Once 10 calendar days after installation.

Preventative Maintenance One (1) Per year

On-site repair visits Unlimited Within 3 business days of NIST request

IX. DELIVERY

Delivery shall be F.O.B Destination and shall occur in accordance with the delivery due dates provided in the above table.

FOB Destination means: The contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. The contractor shall deliver all Line Items to:

IBBR

9600 Gudelsky Drive

Rockville, MD 20850

C/O Kyle Anderson

X. INSPECTION & ACCEPTANCE CRITERIA

In addition to the inspection and acceptance terms articulated in 52.212-4, the Contractor shall demonstrate that all performance specifications are met.

XI. MISCELLANEOUS INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST-IBBR is a restricted campus. An identification badge is required for access for entry into buildings and may be obtained from the security desk upon arrival.

DOC IT Security Policy media sanitization requirements (MP-6) must be followed.

Identification Badges: Contractor employees shall comply with NIST-IBBR identification and access requirements. Each Contractor employee shall wear a visible identification badge provided by the NIST-IBBR security desk.